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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014525
Receipt No. R000016880
Scientific Title A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome
Date of disclosure of the study information 2014/07/31
Last modified on 2014/07/09

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Basic information
Public title A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome
Acronym Efficacy and safety of the combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts for metabolic syndrome
Scientific Title A randomized, placebo-controlled study on efficacy and safety of combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts in patients with metabolic syndrome
Scientific Title:Acronym Efficacy and safety of the combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts for metabolic syndrome
Region
Japan

Condition
Condition Metabolic syndrome
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of the combinational administration of mangosteen pericarps extracts and lychee fruit pericarps extracts for metabolic syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area, body weight(body mass index), abdominal circumstance, blood pressure, triglyceride, HDL-cholesterol, blood glucose
Key secondary outcomes Subcutaneous fat area, total fat area, adiponectin, HMW adiponectin, leptin, adiponectin/ leptin, HMW adiponectin/ total adiponectin, HMW adiponectin/ leptin, questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of placebo capsules for 12 consecutive week
Interventions/Control_2 Ingestion of capsules include extract of pericarp of mangosteen and extract of lychee for 12 consecutive weeks
Interventions/Control_3 Ingestion of capsules include extract of pericarp of mangosteen for 12 consecutive weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Japanese males and females between the ages of 35 and 65
2. abdominal circumference greater or equal 85cm in males and 90 cm in female on preliminary examination
3. applicable to more than two of three following indexes on preliminary examination; blood pressure greater or equal 130/85 mm Hg, triglycerides greater or equal 150mg/dL or serum high-density lipoprotein cholesterol (HDL-C) less 40 mg/dL, blood glucose greater or equal 110 mg/dL, body weight less100 kg, or body mass index greater or equal 25 kg/m2
Key exclusion criteria 1. having exercise or diets for reducing body weight
2. having the medicines or dietary supplements affecting body fat, serum triglyceride, or lipid metabolism potentially
3. having foods fortified with mangosteen or lychee extracts
4. with severe abnormalities of blood pressure or blood test
5. excessive habitual smoker or alcohol addict or extremely irregular food habits person
6. with severe disease receiving treatment
7. needing emergent treatment to diabetes, hepatopathy, renal or heart disease
8. having possibilities of emerging allergy related to the study
9. with pregnant (including with pregnant in plan), or in the lactation period
10. judged to be inadequate by the questionnaire of lifestyles
11. judged to be inadequate by biochemical assessment in blood on preliminary examination
12. taking part in other clinical trials within a month from the initiation of this clinical trial
13. judged to be inadequate by the doctors responsible for this clinical study.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Sumio Kondo
Organization Medical Corporation Kenshokai, Fukushima Healthcare Center
Division name Director
Zip code
Address 2-12-16, Tamagawa, Fukushima-ku, Osaka 553-0004
TEL 06-6441-6848
Email ko283434@ares.eonet.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Muneaki Iizuka
Organization Total Technological Consultant Co., Ltd.(TTC)
Division name Clinical Research Planning Dept.
Zip code
Address 1-20-2 Ebisu Nishi, Shibuya-ku, Tokyo 150-0021, Seibu Shinyokinko Ebisu Bldg
TEL 03-5459-5329
Homepage URL
Email m.iizuka@ttc-tokyo.co.jp

Sponsor
Institute Total Technological Consultant Co., Ltd.(TTC)
Institute
Department

Funding Source
Organization Lotte Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人健昌会 福島健康管理センター(Medical Corporation Kenshokai,Fukushima Healthcare Center)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 04 Month 24 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 09 Day
Last modified on
2014 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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